Back to Results
First PageMeta Content
Health / Center for Devices and Radiological Health / Medical device / Premarket approval / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Adverse event / Medicine / Food and Drug Administration / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
Add to Reading List

Document Date: 2014-06-10 14:26:13

Open Document

File Size: 43,37 KB

Share Result on Facebook

City

Rockville / Tarrytown / /

Company

In Vitro Diagnostics / Regulatory Affairs Siemens Healthcare Diagnostics / /

Currency

pence / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / /

MedicalCondition

hepatitis B / serious injury / infection / chronic hepatitis B / /

MusicGroup

Ph.D. / /

OperatingSystem

XP / /

Organization

Microbiology Devices Office / Radiological Health PMA Document Mail Center / Food and Drug Administration / Center for Devices and Radiological Health / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / /

Person

Mary Seeger / Silver Spring / Sally A. Hojvat / Stephen J. Lovell / Michael Wiack / /

/

Position

Director Division / Senior Manager / /

Product

WO66-G609 / PMA supplement / /

ProvinceOrState

Maryland / New York / /

URL

www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm / www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274.h / www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/P / www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm / /

SocialTag